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US005484.401A
United States Patent (19) 11) Patent Number: 5,484,401
Rodriguez et al. (45) Date of Patent: Jan. 16, 1996
(54) TREATMENT METHOD FOR PLEURAL 4,929,235 5/1990 Merry et al. ............................ 604/256
EFFUSION 4,944,732 7/1990 Russo ...................................... 604/256
4,946,449 8/1990 Davis, Jr. . ... 604/256
(75) Inventors: Michael Rodriguez, Nashville, Tenn.; 4,960,412 10/1990 Fink ................. ... 604/256
Bonnie B. Vivian, Evergreen; Shirley 4,973,311 11/1990 Iwakoski et al. .... ... 604/35
K. Freeman, Pine, both of Colo. 5,009,636 4/1991 Wortley et al. ...... ... 604/280
5,057,084 10/1991 Ensminger et al. . ... 604/256
5,061,255 10/1991 Greenfield et al. .. ... 604/35
(73) Assignee: Denver Biomaterials, Inc., Evergreen, 5,064,416 11/1991 Newgard et al. ... ... 604/256
Colo. 5,098,405 3/1992 Peterson et al. ........................ 604/256
5,106,054 4/1992 Mollenauer et al. .
(21) Appl. No.: 251,692 5,141,499 8/1992 Zappacosta ............................. 604/280
5,156,597 10/1992 Verrett et al. .
22) Filed: May 31, 1994 5,207,655 5/1993 Sheridan ................................. 604/280
Related U.S. Application Data Primary Examiner-Paul J. Hirsch
Attorney, Agent, or Firm-Beaton & Folsom
63 Continuation-in-part of Ser. No. 971,722, Nov. 4, 1992, 57) ABSTRACT
abandoned.
(51) Int. Cl. .................... A61M 39/04; A61M 39/24 A method for treating a pleural effusion condition by estab
52) U.S. Cl. ................................................. 604/28; 604/49 lishing fluid communication with a pleural space, using a
(58) Field of Search ..................................... 604/175, 280, catheter attached to a valve that is normally closed but
604/49, 28, 167, 256 openable by the insertion of a tube in the side opposite the
catheter. The catheteris implanted into the pleural space and
56) References Cited is periodically accessed by inserting a tube into the valve on
the side opposite the catheter to add or remove fluid to and
U.S. PATENT DOCUMENTS from the pleural space using a negative pressure source.
4,669,463 6/1987 McConnell .............................. 604/256
4,874,377 10/1989 Newgard et al. ....................... 604/256 2 Claims, 3 Drawing Sheets
U.S. Patent Jan. 16, 1996 Sheet 1 of 3 5,484,401
U.S. Patent Jan. 16, 1996 Sheet 2 of 3 5,484,401

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U.S. Patent Jan. 16, 1996 Sheet 3 of 3 5,484,401
 5,484.401
1.
TREATMENT METHOD FOR PLEURAL
EFFUSION
This application is a continuation-in-part of application
Ser. No. 07/971,722 filed Nov. 4, 1992 abandoned.
FIELD OF THE INVENTION
The present invention relates to the field of removing
pleural effusion fluids and, in particular, to a therapeutic
treatment method for removing pleural effusion fluid using
long-term catheter implantation into the pleural space.
BACKGROUND OF THE INVENTION
Pleural effusion refers to the effusion of fluid into the
pleural space. The pleural space normally contains approxi
mately 5 to 20 ml of fluid. The pH, glucose and electrolytes
of the fluid are equilibrated with plasma, but the fluid is
relatively protein-free. The fluid is the result of the hydro
static-oncotic pressure of the capillaries of the parietal
pleura. About 80-90% of the fluid is reabsorbed by the
pulmonary venous capillaries of the visceral pleura, and the
remaining 10-20% is reabsorbed by the pleural lymphatic
system. The turnover of fluid in the pleural space is normally
quite rapid-roughly 35 to 75% per hour, so that 5 to 10
liters of fluid move through the pleural space each day.
A disruption in the balance between the movement of
fluid into the pleural space and the movement of fluid out of
the pleural space may produce excessive fluid accumulation
in the pleural space. Such disruptions may include, for
example, (1) increased capillary permeability resulting from
inflammatory processes such as pneumonia, (2) increased
hydrostatic pressure as in congestive heart failure, (3)
increased negative intrapleural pressure as seen in atelecta
sis, (4) decreased oncotic pressure as occurs in the nephrotic
syndrome with hypoalbuminemia, and (5) increased oncotic
pressure of pleural fluid as occurs in the inflammation of
pleural tumor growth or infection. Pleural effusion is par
ticularly common in patients with disseminated breast can
cer, lung cancer or lymphatic cancer and patients with
congestive heart failure, but also occurs in patients with
nearly all other forms of malignancy.
The clinical manifestations of pleural effusion include
dyspnea, cough and chest pain which diminish the patient's
quality of life. Although pleural effusion typically occurs
toward the end of terminal malignancies such as breast
cancer, it occurs earlier in other diseases. Therefore relieving
the clinical manifestations of pleural effusion is of a real and
extended advantage to the patient. For example, non-breast
cancer patients with pleural effusion have been known to
survive for years. See "Pleural Effusion in Cancer Patients',
Izbicki, et al., Cancer October 1975, p. 1511.
There are a number of treatments for pleural effusion. If
the patient is asymptomatic and the effusion is known to be
malignant or paramalignant, treatment may not be required.
Such patients may develop progressive pleural effusions that
eventually do produce symptoms requiring treatment, but
some will reach a stage where the effusions and reabsorption
reach an equilibrium that is still asymptomatic and does not
necessitate treatment.
Pleurectomy and pleural abrasion is generally effective in
obliterating the pleural space and, thus, controlling the
malignant pleural effusion. This procedure is done in many
patients who undergo thoracotomy for an undiagnosed pleu
ral effusion and are found to have malignancy, since this
would prevent the subsequent development of a symptom
2
atic pleural effusion. However, pleurectomy is a major
surgical procedure associated with substantial morbidity and
some mortality. Therefore, this procedure is usually reserved
for patients with an expected survival of at least several
months, who are in relative good condition, who have a
trapped lung, or who have failed a sclerosing agent proce
dure.
In general, systemic chemotherapy is disappointing for
10
the control of malignant pleural effusions. However, patients
with lymphoma, breast cancer, or small cell carcinoma of the
lung may obtain an excellent response to chemotherapy.
Another approach to removing fluid from the pleural
space is to surgically implant a chest tube. Such tubes are
15
commonly quite rigid and fairly large in diameter and are
implanted by making a surgical incision and spreading apart
adjacent ribs to fit the tube into place. Such procedures are
painful to the patient, both initially when the chest tube is
inserted and during the time it remains within the pleural
space.
20
Thoracentesis is a common approach to removing pleural
fluid, in which a needled catheter is introduced into the
pleural space through an incision in the chest cavity and fluid
is positively drawn out through the catheter using a syringe
or a vacuum source. The procedure may also include aspi
25
ration utilizing a separate syringe. There are a number of
difficulties in thoracentesis, including the risk of puncturing
a lung with the catheter tip or with the needle used to
introduce the catheter, the risk of collapsing a lung by
30 relieving the negative pressure in the pleural space, the
possibility of aggravating the pleural effusion by stimulating
fluid production in the introduction of the catheter, and the
risk of infection. One of the primary difficulties with ordi
nary thoracentesis procedures is that fluid reaccumulates in
35 the pleural space relatively quickly after the procedure is
performed, and so it is necessary to perform the procedure
repeatedly-as often as every few days. In fact, some studies
found that the fluid re-accumulates in one to three days in
most cases and re-accumulates within a month in 97% of the
40 cases studied. See "Diagnosis and Treatment of Malignant
Pleural Effusion', F. J. Hausheer, J. W. Yarbro, Seminars in
Oncology, March 1985, p. 54; "Malignant Effusion', Ander
son, et al., Cancer, April 1974, p. 916. Of course, each time
the procedure is repeated the risks identified above are
45 heightened. Moreover, the comfort to the patient resulting
from the procedure begins to be offset by the discomfort of
the procedure itself.
There is therefore a need for a treatment method for
removing pleural effusion which does not require repeated
50 invasion of the pleural space in a manner which produces
repeated patient discomfort, infection risks, risks of acci
dental trauma to the lungs, and the potential for stimulating
fluid production. Ideally, such a method and apparatus
would employ instruments that are relatively simple in
55 design and manufacture and would be within the capabilities
of ordinary physicians to use, and would involve at least the
possibility of reducing future pleural effusion.
SUMMARY OF THE INVENTION
60
The present invention is a method for draining pleural
effusion fluids using a special catheter device that is
implanted in the pleural space for extended periods of time.
The proximal end of the catheter is fenestrated to receive the
65 pleural fluid and the distal end is in communication with a
vacuum source or negative pressure source to draw fluid
from the pleural space into the catheter through the multiple
 5,484.401
3 4
orifices, and through the catheter toward the negative pres
S SOCC
Between the negative pressure source and the distal end of
the catheter is a valve to close the catheter when the negative
pressure source is not connected to the catheter between
fluid removals, and to open the catheter when the negative
pressure source is connected to the catheter for the removal
of fluid. The valve is normally closed, so that fluid does not
drain through the catheter and air does not enter the catheter
when the negative pressure source is not connected to the
catheter, but opens when the apparatus is configured for fluid
removal, as upon connection of the negative pressure source.
The valve is also designed such that a tube can be introduced
into the valve to apply fluids therein, thereby allowing the
introduction of materials into the pleural space if desired.
The valve may be capped by a cap which may include an
antimicrobial and/or antibacterial solution to avoid contami
nation.
The treatment method is straight-forward and highly
effective in that accumulated pleural effusion fluid can be
drained whenever desired without re-entering the pleural
space. The design of the implanted instrument is such that
the chance of infection or contamination is minimized.
Moreover, unlike other draining procedures such as periodic
thoracentesis, it is believed that the frequent draining of the
pleural space may produce a sclerosis that will prevent or
lessen further effusion, thereby alleviating the condition
altogether.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a pictorial view of the catheter of the present
invention prepared for implantation.
FIG. 2 is a partially sectional view of the valve utilized in
an embodiment of the invention.
FIG. 3 is a partially sectional view of the valve of FIG. 2,
with a tube inserted therein to open the valve.
FIG. 4 is a diagrammatic view of the apparatus of the
present invention including a vacuum bottle to produce a
negative pressure on the proximal end of the catheter.
FIG. 5 is a diagrammatic view of the apparatus of the
present invention including a syringe to introduce fluid into
the catheter.
FIG. 6 is a partially sectional view of the valve utilized in
an embodiment of the invention with a valve cap.
DETAILED DESCRIPTION OF THE
INVENTION
A pictorial view of a catheter 12 for use with the present
invention is shown in FIG.1. The catheter 12 in a preferred
embodiment has a proximal end 14 and a distal end 16 may
be about twenty-four inches long, the proximal ten inches
being fenestrated with a series of holes 18 allowing fluid
communication between the exterior of the catheter and the
lumen. The catheter is made of a flexible material such as
silicone rubber. A few inches distal from the holes 18 may
be a Dacron cuff 9.
The catheter is implanted into the pleural space using
procedures known in the art. For example, one technique is
to make an incision between adjacentribs of the patient's rib
cage in a direction superiorly and posteriorly toward the
pleural space. The pleural space is aspirated using a needle
and then a J-wire is inserted through the needle and into the
pleural space and the needle is removed. Asheath and dilator
are threaded over the J-wire and into the pleural space and
the J-wire is removed. The dilator is removed from within
the sheath. The catheter is then threaded through the sheath
and into the pleural space and the sheath is removed.
The distal end 16 of the catheter 12 is attached to a valve
60. The valve 60 is shown in detail in FIG. 2. As shown in
FIG. 2, the valve includes a body 62 having a distal portion
64 and a proximal portion 65 which are attached to one
another by an adhesive or other suitable means. The end 66
of the distal portion 64 and the end 69 of the proximal
10 portion 65 each have a hole, and the centers of those portions
64 and 65 are hollowed out, thereby forming a passageway
68 through the valve body 62. Positioned within this pas
sageway 68 is a "duckbill' valve 72 which is of the type
known in the art consisting of an elastomeric, molded,
15 one-piece dome containing a slit in the center of the domed
portion. The duckbill valve 72 may be opened by inserting
an elongated member through the passageway 68 from the
distal portion 64 to pry apart the valve in the manner
described below. Adjacent to the duckbill valve 72 toward
20 the distal portion 64 is an elastomeric seal 78. The elasto
meric seal 78 is a disk-shaped element having a hole 79
through the center to seal against the outside of the drainage
tube 110 or introduction tube 150 in the manner described
below.
25
Fluid is withdrawn from the pleural space by inserting a
drainage tube 110 into the distal portion 64 of the valve 60
as shown in FIGS. 3-4. The drainage tube is slightly larger
in its outside diameter then the hole 79 in the elastomeric
30
seal 78, thereby ensuring that a seal is created between the
elastomeric seal 78 and the outside of the drainage tube to
prevent fluid from leaking. The insertion of the drainage
tube 110 into the valve 60 opens the duckbill valve 72 and
thereby accesses the interior of the catheter 12. As shown in
35
FIG. 4, the other end of the drainage tube 110 may be in
communication with a vacuum bottle 114 or any other
negative pressure source such as a mechanical device to
draw fluid from the pleural space, into the catheter, through
the catheter and the valve, through the drainage tube and into
a fluid collection reservoir or the vacuum bottle.
40
The fluid removal procedure is discontinued by simply
withdrawing the drainage tube 110 from the valve 60. As the
end of the drainage tube comes out of the duckbill valve 72,
the valve closes and prevents further fluid from flowing out
45 of the valve and also prevents air from entering the catheter
and possibly flowing into the pleural space.
A similar procedure can be used to introduce material into
the pleural space as shown in FIG. 5, using the same
implanted catheter 12 and attached valve 60. Rather than
50 utilizing a drainage tube 110, an introduction tube 150 of the
same configuration is used. One end of the introduction tube
is attached to a syringe 152 (or infusion pump or other
known device for introducing fluid into the body) and the
other end is inserted into the valve 60. The end of the
55 introduction tube 150, like the end of the drainage tube 110
previously described, goes through and seals against the
hole 79 of the elastomeric seal 78, and then opens and goes
through the duckbill valve 72 to access the catheter lumen.
Thus, leak-proof communication is established from the
60 syringe interior to the pleural space.
The distal end 64 of the valve 60 may be capped with a
cap 140 as shown in FIG. 6 when fluid is not being removed
from or introduced to the pleural space. The cap 140 is not
necessary to close the valve, since the valve is already closed
65 by the duckbill valve 72 in the passageway 68 when there is
no drainage tube or introduction tube. However, it may still
be desirable to cap the valve to prevent contamination of the
 5,484.401
5 6
passageway 68 and to reduce the possibility of infection.
The cap 140 may have a threaded sleeve 142 to mate with
threads on the valve 60. To further reduce the possibility of
infection, the cap 140 may be of the sterilant-filled type in
which the cap is stored in a chamber with mating threads
which is filled with a sterilant such as iodine when the cap
is not in use.
The present treatment method is superior to palliative
treatments known in the art in several important respects.
The present treatment method requires only a single inva
sion of the pleural space, as contrasted with multiple inva
sion procedures such as periodic thoracentesis. The in
dwelling catheter is readily available at any time for
drainage of pleural effusion fluid as required. Also, the
catheter can be used to introduce substances such as a
sclerosing agent if desired. Even though the treatment
involves an indwelling catheter, the special design of the
instruments as described minimize the likelihood of infec
tion or contamination which would ordinarily be expected
for an in-dwelling catheter. Perhaps most importantly, it is
believed that, at least for some patients, the method is not
merely palliative but is remedial as well due to a sclerosing
effect in the pleural space produced by the dryness resulting
from frequent draining.
We claim:
1. Method of producing a sclerosing effect in the pleural
of a human to reduce pleural effusion, comprising inserting
a catheter through the chest wall of the patient so that an end
10 of the catheter is in the pleural space; repeatedly accessing
the pleural space to repeatedly drain pleural effusion from
the pleural space by inserting a tube into a valve in the
catheter to open the valve and access the catheter, to produce
a sclerosing effect in the pleural space to reduce pleural
15 effusion.
2. The method of claim 1, further comprising introducing
a sclerosing agent into the pleural space through the tube and
catheter.